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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Low RiskFDA Drug
Medications & Supplements/Prescription Drugs

SCA Pharmaceuticals, LLC.: Labetalol HCl Injection Recalled for Incorrect Expiration Dates

Agency Publication Date: March 19, 2018
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Summary

SCA Pharmaceuticals is recalling 480 syringes of Labetalol HCl injection (20 mg/4 mL) because the product labels show the wrong compounding and expiration dates. The labels incorrectly state a compounding date of 12/27/2018 and a use-by date of 03/27/2019, when the actual compounding date was 12/27/2017 and the correct use-by date was 03/27/2018. This error could lead to the use of medication that is nearly a year past its intended shelf life. Consumers should contact their healthcare provider or pharmacist for guidance regarding any affected syringes.

Risk

Using medication past its intended expiration date may result in reduced drug potency or compromised stability, potentially failing to provide the necessary blood pressure management for patients receiving this intravenous treatment.

What You Should Do

  1. Immediately check your supply for Labetalol HCl injection (20 mg/4 mL) in 4 mL syringes with NDC 70004-0700-28 and UPC 70004070028.
  2. Look for syringes marked with lot number 1217000213 and an expiration date of 03/27/2019.
  3. If you identify an affected syringe, stop using it immediately and contact your healthcare provider or pharmacist for guidance.
  4. Return any unused product from the affected lot to the pharmacy or place of purchase for a refund.
  5. Contact SCA Pharmaceuticals at their Windsor, CT facility for further instructions regarding the return or replacement of these syringes.
  6. For additional questions or to report a problem, contact the FDA Consumer Complaint line at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

๐Ÿ’ฐFull Refund

Contact healthcare provider and return for refund

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: labetalol HCl injection 20 mg/4 mL (5mg/mL), 4 mL syringe
Model:
NDC 70004-0700-28
Recall #: D-0603-2018
UPC Codes:
70004070028
Lot Numbers:
1217000213 (Exp 03/27/2019)
Date Ranges: 03/27/2019

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 79265
Status: Resolved
Manufacturer: SCA Pharmaceuticals, LLC.
Sold By: hospitals; clinics
Manufactured In: United States
Units Affected: 480 syringes
Distributed To: Georgia, Nebraska, Pennsylvania

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.